The tariff classification of Temozolomide capsules and Metronidazole tablets in dosage form, from India

N279377 September 27, 2016 CLA-2-30:OT:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 3004.90.9110; 3004.90.9115 Mr. Pradeep Shah Zydus Pharmaceuticals USA, Inc. 73 Route 31 North Pennington, NJ 08534 RE: The tariff classification of Temozolomide capsules and Metronidazole tablets in dosage form, from India Dear Mr. Shah: In your letter dated September 6, 2016, you requested a tariff classification ruling. Temozolomide, imported in 5, 20, 100, 140, 180 and 250 mg capsules, is a medicinal preparation containing Temozolomide, an alkylating agent, as the active ingredient. It is indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy. Metronidazole, imported in 250 and 500 mg tablets, is a medicinal preparation containing Metronidazole, an antibacterial agent, as the active ingredient. It is indicated for the prevention and treatment of certain bacterial and protozoal infections. The applicable subheading for the Temozolomide capsules in dosage form will be 3004.90.9115, Harmonized Tariff Schedule of the United States (HTSUS), which provides for "Medicaments ... consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses… or in forms or packings for retail sale: Other: Other: Other: Antineoplastic and immunosuppressive medicaments." The rate of duty will be free. The applicable subheading for the Metronidazole tablets in dosage form will be 3004.90.9110, HTSUS, which provides for "Medicaments … consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses … or in forms or packings for retail sale: Other: Other: Other: Anti-infective medicaments: Other." The rate of duty will be free. Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on World Wide Web at https://hts.usitc.gov/current. This merchandise may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which are administered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, and Cosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or by visiting their website at www.fda.gov. This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177). A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, contact National Import Specialist Judy Lee at [email protected]. Sincerely, Steven A. Mack Director National Commodity Specialist Division